Status:
COMPLETED
A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer
Lead Sponsor:
Amgen
Conditions:
Advanced Hepatocellular Carcinoma
Inoperable Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether AMG 386, in combination with Sorafenib, is effective in the treatment of advanced or inoperable Hepatocellular cancer in subjects who have not receive...
Detailed Description
The primary objective is to evaluate the efficacy of AMG 386 in combination with sorafenib as measured by the progression free survival (PFS) rate at 4 months in subjects with advanced or inoperable h...
Eligibility Criteria
Inclusion
- Histologically confirmed advanced or inoperable HCC
- Child-Pugh A liver function score
- Measurable disease with at least one unidimensionally measurable lesion per RECIST 1.0 guidelines with modifications
- Adequate organ and hematological function
- Men or women greater than or equal to 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
Exclusion
- Subject is eligible for a liver transplant per investigators discretion
- Any previous systemic chemotherapy for HCC
- History of arterial or venous thromboembolism within 12 months prior to enrollment
- History of clinically significant bleeding within 6 months prior to enrollment
- History of central nervous system metastases
- Clinically significant cardiovascular disease within 12 months
- Uncontrolled hypertension
- Subjects with a history of prior malignancy
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00872014
Start Date
August 1 2009
End Date
June 1 2015
Last Update
April 4 2016
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